BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESOFLIP

    MDR report key: 12440915 · Received September 8, 2021

    Report

    Report Number
    3006897778-2021-00002
    Event Type
    Injury
    Date Received
    September 8, 2021
    Date of Event
    August 17, 2021
    Report Date
    September 8, 2021
    Manufacturer
    CROSPON LTD
    Product Code
    PID
    UDI-DI
    05391530810043
    PMA / PMN Number
    K132337
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    ACCORDING TO THE REPORTER, THERE WAS AN ESOPHAGEAL PERFORATION DURING THE PROCEDURE. THE CATHETER LOST PROCEDURE, THEY DEFLATED THEN INFLATED, BUT DID NOT REACH 20 MILLILITER, DEFLATED AGAIN, AND THEY NOTICED THE PERFORATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1337234 ESOFLIP ESOPHAGEAL DILATOR BALLOON WITH OR WITHOUT ELE PID CROSPON LTD ES-330 20A1132JZ 05391530810043

    Patients

    Seq Age Sex Outcome Treatment
    1 Other